Senior Physician, Patient Safety; Senior Drug Safety Physician

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.

About the Role

As a Senior Physician in Patient Safety
, you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross‑functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.

Key Accountabilities:

• Maintaining a good working knowledge of the adverse event/safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
• Maintaining an awareness of global regulatory requirements, reporting obligations and organising workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
• Interacting with internal and external stakeholders for resolving issues
• Attending and/or presenting at client/cross‑functional meetings along with other stakeholders. Working as subject matter experts (SMEs)
• Assisting the Project Lead/Functional Lead for audits and inspections
• Providing inputs for process improvements
• Working closely with Project Lead/Functional Lead for process coordination and to ensure meeting all KPIs for the process
• Functioning as pharmacovigilance representative/safety scientist
• Attending/supporting bid defense meetings
• Actively mentoring Patient Safety Physicians to develop their skills and expertise

Case report medical review (as applicable)

• Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement), clinical trial, and literature cases including combination products (drug‑device) according to client/Parexel SOPs and liaising with the client as required
• Writing pharmacovigilance/marketing authorization holder (MAH) comment and assessing company causality
• Reviewing appropriateness of medical content in narrative for medical coherence
• Assessing seriousness, listedness/expectedness of reported events
• Providing medical inputs to case processing team
• Raising appropriate follow‑up queries for relevant information from the reporter/HCP (health care professional)
• Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate MedDRA code, and reviewing narrative
• Identifying and resolving case issues, coordinating with client therapeutic/legal team
• Providing guidance to junior physicians on case assessment methodologies

Periodic reports (as applicable)

• Reviewing and/or authoring aggregate reports for medical content and consistency in accordance with client requirements and SOPs
• Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, PBRERs, PSURs, SERs, HA response documents, DSURs, COs, ACOs, HHEs, etc.
• Clinical expert statements and other documents as required
• Reviewing reports assessed by junior team members for accuracy and completeness

Medical monitoring (as applicable)

• Answering day‑to‑day medical and scientific questions, providing daily medical support to Parexel staff or site investigator/study coordinator, as needed
• Reviewing and signing off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; providing sponsors with periodic experience reports summarising adverse events as required by the sponsor or authorities
• Attending and presenting material such as therapeutic area training, as requested, at internal and external meetings (such as investigator…